TEER plus electrical cardioversion for severe mitral regurgitation with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and potential benefit of combining transcatheter edge-to-edge repair (TEER) with electrical cardioversion in adults who have severe mitral regurgitation and atrial fibrillation after a TEER procedure. The primary goal is to determine if the combined approach reduces a composite of all-cause death, heart failure hospitalization, and stroke within 12 months, compared with TEER alone. Eligibility requires a successful TEER with residual MR < 2+, no left atrial thrombus, suitable anatomy for cardioversion, and ability to follow up. Key exclusions include very low ejection fraction, recent stroke, contraindications to anticoagulation or antiarrhythmic therapy, and conditions likely to affect treatment assessment. The study is led by the Second Affiliated Hospital, Zhejiang University School of Medicine, with no listed collaborators and site in Hangzhou, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years;
2. Successful TEER procedure with residual mitral regurgitation grade \< 2+;
3. No left atrial thrombus, no severe cardiomyopathy, left atrial anteroposterior diameter \< 5.5 cm, and anatomically suitable for electrical cardioversion;
4. Ability to understand the study objectives, voluntarily sign the informed consent form, and willingness to comply with required examinations and clinical follow-up.

Exclusion Criteria:

* 1\. Left ventricular ejection fraction \< 20%; 2. Stroke or transient ischemic attack within 30 days; 3. Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs; 4. Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.; 5. Life expectancy \< 12 months; 6. Any other anatomical, concomitant disease, medical, social, or psychological condition that, in the investigator's judgment, may limit the participant's ability to comply with study requirements or affect the scientific validity of the study results.

Where it's running

• The Second Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jianan Wang
• Email: wangjianan111@zju.edu.cn
• Phone: 0571-87784804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.